SAMITAL® improves chemo/radiotherapy-induced oral mucositis in patients with head and neck cancer: results of a randomized, placebo-controlled, single-blind Phase II study
Autor: | D. Pawar, Massimo Ronchi, Giovanna Petrangolini, A. Riva, P. Morazzoni, E. Bombardelli, R. S. Neve, S. Kalgane |
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Rok vydání: | 2012 |
Předmět: |
Adult
Male Oncology medicine.medical_specialty Visual analogue scale Pain Placebo Severity of Illness Index law.invention Randomized controlled trial law Internal medicine Severity of illness medicine Mucositis Humans Single-Blind Method Adverse effect Aged Stomatitis Plant Extracts business.industry Head and neck cancer Chemoradiotherapy Middle Aged medicine.disease Clinical trial Treatment Outcome Head and Neck Neoplasms Quality of Life Female business |
Zdroj: | Supportive Care in Cancer. 21:827-834 |
ISSN: | 1433-7339 0941-4355 |
Popis: | This randomised, placebo-controlled single-blind trial investigated the safety and efficacy of SAMITAL®, a formulation of highly standardised botanical extracts, in the treatment of chemo/radiotherapy-induced oral mucositis (OM) in patients with head and neck cancer. Patients received SAMITAL® or placebo four times daily for up to 50 days during scheduled chemo/radiotherapy. Severity of OM was monitored according to a modified WHO severity scale, and pain and quality-of-life assessments were based on the effect of symptoms of OM on relevant daily activities, according to a visual analogue scale. Mean scores for the severity of OM were significantly (p |
Databáze: | OpenAIRE |
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